SBIR-STTR Award

A Microneedle Array System for Transcutaneous Nerve Mapping
Award last edited on: 6/12/17

Sponsored Program
SBIR
Awarding Agency
NIH : NINDS
Total Award Amount
$2,481,215
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
James Ross

Company Information

Axion Biosystems Inc (AKA: Axion Biosystems LLC)

1819 Peachtree Road NE Suite 350
Atlanta, GA 30309
   (404) 477-2557
   info@axionbio.com
   www.axionbiosystems.com
Location: Single
Congr. District: 05
County: Fulton

Phase I

Contract Number: 1R43NS065545-01A1
Start Date: 9/1/09    Completed: 8/31/11
Phase I year
2009
Phase I Amount
$556,000
The proposed study utilizes novel electronics and microfabrication techniques to create a non-invasive, automated platform for targeted monitoring and manipulation of human neural tissue. This research will enable rapid advancements in both basic research and clinical medical devices, with applications to neuropathological diagnostics, advanced therapeutics, and neural prosthetics. Phase I involves three significant developments for non-invasive neurotechnology. Aim 1 will develop high-resolution and low-noise skin surface electrode arrays. Each electrode within the array will contain low-cost micropat- terned needles, which dramatically decrease electrode impedance by painlessly piercing the topmost layer of skin, allowing for high spatial resolution without any sacrifice in signal-to-noise ratios. Aim 2 will develop scalable simultaneous stimulation and re- cording electronics to recover signals traditionally obscured by stimulation artifacts. The recovered data, combined with the ability to simultaneously interact with dozens of skin- surface electrodes, will provide new measures of transcutaneous nerve and muscle activ- ity. Finally, Aim 3 will combine the technological developments of Aims 1 and 2 to dem- onstrate the segmentation and characterization of nerves through the skin. In addition to reducing the complexity, pain, and operator training required to perform traditional nerve conduction studies (NCS), this platform will enable a wide range of basic research studies as well as the creation of novel neuromodulation devices. Phase 2 will focus on increasing the number of channels serviced by the array and electronics, reducing the form factor and processing requirements for the electronics, and providing signal- processing hardware and algorithms for real-time information extraction and neural control.

Public Health Relevance:
This research project leverages novel electronic and fabrication technologies to produce a non-invasive automated toolset for the study of nerve, muscle, and brain tissue. Ulti- mately, this development will facilitate medical and scientific discoveries that will enable the diagnosis and therapeutic treatment of neuromuscular diseases.

Public Health Relevance Statement:
This research project leverages novel electronic and fabrication technologies to produce a non-invasive automated toolset for the study of nerve, muscle, and brain tissue. Ulti- mately, this development will facilitate medical and scientific discoveries that will enable the diagnosis and therapeutic treatment of neuromuscular diseases.

NIH Spending Category:
Bioengineering; Clinical Research; Networking and Information Technology R&D; Neurosciences

Project Terms:
3-D; 3-Dimensional; Algorithms; Analysis, Data; Area; Artifacts; Basic Research; Basic Science; Body Tissues; Cell Communication and Signaling; Cell Signaling; Charge; Clinical; Computer Programs; Computer software; Custom; Data; Data Analyses; Development; Devices; Diagnosis; Diagnostic; ECG; EKG; EMG; Electrical Impedance; Electrocardiogram; Electrocardiography; Electrodes; Electrodes, Miniaturized; Electromyography; Electronics; Evoked Potentials; Foundations; Gel; Goals; Head; Human; Human, General; Impedance; Individual; Intracellular Communication and Signaling; Intraoperative Monitoring; Investigators; Man (Taxonomy); Man, Modern; Manuals; Maps; Measures; Medical; Medical Device; Methods and Techniques; Methods, Other; Microelectrodes; Microfabrication; Monitor; Morphologic artifacts; Muscle; Muscle Tissue; NRVS-SYS; Needles; Nerve; Nerve Conduction; Nervous; Nervous System; Nervous system structure; Neural Conduction; Neurologic Body System; Neurologic Organ System; Neuromuscular Diseases; Noise; Pain; Painful; Patients; Peripheral Nerves; Phase; Physicians; Physiologic; Physiological; Preparation; Process; Psyche structure; R01 Mechanism; R01 Program; RPG; Research; Research Grants; Research Personnel; Research Project Grants; Research Projects; Research Projects, R-Series; Researchers; Resolution; Retinal blind spot; Services; Signal Transduction; Signal Transduction Systems; Signaling; Skin; Software; Spots, Blind; Staging; Stimulus; Surface; System; System, LOINC Axis 4; Techniques; Technology; Testing; Therapeutic; Time; Tissues; Training; Tweens; Variant; Variation; base; biological signal transduction; brain tissue; computer program/software; computerized data processing; cost; data processing; density; disease diagnosis; electric impedance; experiment; experimental research; experimental study; improved; mental; miniaturize; myoneural disorder; neural; neural control; neural prosthesis; neural prosthetic; neural regulation; neuromuscular disorder; neuroregulation; neurotechnology; novel; public health relevance; relating to nervous system; research study; response; signal processing

Phase II

Contract Number: 5R43NS065545-02
Start Date: 9/1/09    Completed: 8/31/11
Phase II year
2010
(last award dollars: 2016)
Phase II Amount
$1,925,215

The proposed study utilizes novel electronics and microfabrication techniques to create a non-invasive, automated platform for targeted monitoring and manipulation of human neural tissue. This research will enable rapid advancements in both basic research and clinical medical devices, with applications to neuropathological diagnostics, advanced therapeutics, and neural prosthetics. Phase I involves three significant developments for non-invasive neurotechnology. Aim 1 will develop high-resolution and low-noise skin surface electrode arrays. Each electrode within the array will contain low-cost micropat- terned needles, which dramatically decrease electrode impedance by painlessly piercing the topmost layer of skin, allowing for high spatial resolution without any sacrifice in signal-to-noise ratios. Aim 2 will develop scalable simultaneous stimulation and re- cording electronics to recover signals traditionally obscured by stimulation artifacts. The recovered data, combined with the ability to simultaneously interact with dozens of skin- surface electrodes, will provide new measures of transcutaneous nerve and muscle activ- ity. Finally, Aim 3 will combine the technological developments of Aims 1 and 2 to dem- onstrate the segmentation and characterization of nerves through the skin. In addition to reducing the complexity, pain, and operator training required to perform traditional nerve conduction studies (NCS), this platform will enable a wide range of basic research studies as well as the creation of novel neuromodulation devices. Phase 2 will focus on increasing the number of channels serviced by the array and electronics, reducing the form factor and processing requirements for the electronics, and providing signal- processing hardware and algorithms for real-time information extraction and neural control.

Public Health Relevance:
This research project leverages novel electronic and fabrication technologies to produce a non-invasive automated toolset for the study of nerve, muscle, and brain tissue. Ulti- mately, this development will facilitate medical and scientific discoveries that will enable the diagnosis and therapeutic treatment of neuromuscular diseases.

Thesaurus Terms:
3-D;3-Dimensional;Algorithms;Analysis, Data;Area;Artifacts;Basic Research;Basic Science;Body Tissues;Cell Communication And Signaling;Cell Signaling;Charge;Clinical;Computer Programs;Computer Software;Custom;Data;Data Analyses;Development;Devices;Diagnosis;Diagnostic;Ecg;Ekg;Emg;Electrical Impedance;Electrocardiogram;Electrocardiography;Electrodes;Electrodes, Miniaturized;Electromyography;Electronics;Evoked Potentials;Foundations;Gel;Goals;Head;Human;Human, General;Impedance;Individual;Intracellular Communication And Signaling;Intraoperative Monitoring;Investigators;Man (Taxonomy);Man, Modern;Manuals;Maps;Measures;Medical;Medical Device;Methods And Techniques;Methods, Other;Microelectrodes;Microfabrication;Monitor;Morphologic Artifacts;Muscle;Muscle Tissue;Nrvs-Sys;Needles;Nerve;Nerve Conduction;Nervous;Nervous System;Nervous System Structure;Neural Conduction;Neurologic Body System;Neurologic Organ System;Neuromuscular Diseases;Noise;Pain;Painful;Patients;Peripheral Nerves;Phase;Physicians;Physiologic;Physiological;Preparation;Process;Psyche Structure;R01 Mechanism;R01 Program;Rpg;Research;Research Grants;Research Personnel;Research Project Grants;Research Projects;Research Projects, R-Series;Researchers;Resolution;Retinal Blind Spot;Services;Signal Transduction;Signal Transduction Systems;Signaling;Skin;Software;Spots, Blind;Staging;Stimulus;Surface;System;System, Loinc Axis 4;Techniques;Technology;Testing;Therapeutic;Time;Tissues;Training;Tweens;Variant;Variation;Base;Biological Signal Transduction;Brain Tissue;Computer Program/Software;Computerized Data Processing;Cost;Data Processing;Density;Disease Diagnosis;Electric Impedance;Experiment;Experimental Research;Experimental Study;Improved;Mental;Miniaturize;Myoneural Disorder;Neural;Neural Control;Neural Prosthesis;Neural Prosthetic;Neural Regulation;Neuromuscular Disorder;Neuroregulation;Neurotechnology;Novel;Public Health Relevance;Relating To Nervous System;Research Study;Response;Signal Processing